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Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111042
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Xavier Serra-Aracil
Anna Pallisera-Lloveras
Information provided by (Responsible Party):
Laura Mora-Lopez, Corporacion Parc Tauli

Tracking Information
First Submitted Date September 29, 2019
First Posted Date October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2019)
long-term outcomes [ Time Frame: 2 years ]
survival rates
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 30, 2019)
anastomotic leak [ Time Frame: 30 days ]
surgery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
Official Title Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction
Brief Summary Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.
Detailed Description Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population : patient demographics, physiological status according to the American Society of Anesthesiologist (ASA) score, tumor characteristics and localization, type of surgery, surgical team, stoma formation rate, perioperative morbidity and mortality, tumor stage according to the International Union Against Cancer (UICC)-TNM Classification of Malignant Tumors published by the National Comprehensive Cancer Network (7th edition), administration of adjuvant treatment, local and distant disease recurrence based on CT imaging (and histological tissue if possible), disease-free survival and overall survival.
Condition
  • Stent Occlusion
  • Long-term Oncologic Results
Intervention Device: stenting
stenting procedure in patients diagnosed malignant large bowel occlusion
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 30, 2019)
117
Original Actual Enrollment Same as current
Actual Study Completion Date August 2019
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
  • Elective surgery.
  • Location in transverse, left or sigmoid colon.
  • Patients who signed the informed consent documentation and agreed to undergo the procedure.

Exclusion Criteria:

  • Benign pathology and palliative treatment.
  • Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
  • Previous chemotherapy.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04111042
Other Study ID Numbers TAULI-STENT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There's no sharing plan because the study has finished the recruited time
Responsible Party Laura Mora-Lopez, Corporacion Parc Tauli
Study Sponsor Corporacion Parc Tauli
Collaborators
  • Xavier Serra-Aracil
  • Anna Pallisera-Lloveras
Investigators Not Provided
PRS Account Corporacion Parc Tauli
Verification Date September 2019